Events

Retiro De Equipo (Recall) de Device Recall Forteo teriparatide (rDNA origin) injection starter kits

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Eli Lilly and Company.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58219
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2191-2011
  • Fecha de inicio del evento
    2011-03-17
  • Fecha de publicación del evento
    2011-05-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98738
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lubricant, patient - Product Code KMJ
  • Causa
    Eli lilly and company announced 3/17/2011 that patients should not use the alcohol prep pads made by the triad group that are contained in the black starter kits for forteo [teriparatide (rdna origin) injection] in the united states.The tri-ad group is recalling the alcohol prep pads due to potential contamination with the bacteria, ba-cillus cereus, which could result in life threatening infecti.
  • Acción
    The firm, Eli Lilly and Company, sent two letters entitled "URGENT MEDICAL DEVICE RECALL TRIAD GROUP ALCOHOL PREP PADS INCLUDED IN FORTEO STARTER KITS ALL ALCOHOL PREP PAD LOTS" to its customers. The first letter was dated March 18, 2011 and second follow-up letter was dated March 28, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to examine their inventory of Forteo starter kits; if they have any Forteo starter kits with a black bag, remove and appropriately discard the Triad Group alcohol prep pads; discontinue providing the product with the starter kits; inform any patients that may have received Forteo starter kits containing the Triad Group alcohol prep pads to discontinue use; note: after removing the Triad Group alcohol prep pads, all other components of the Forteo starter kits are acceptable for use: travel bag, pen case, gel packs, needles and instructional materials, and complete and return the enclosed business reply card. "It is important to note that this recall does not affect or involve the Forteo delivery device." For questions pertaining to the recall, contact Triad Group at 262-538-2900. (Please refer to the Triad Group press release issued on January 5, 2011 on the FDA website.) If you have product specific medical questions related to Forteo please call 1-800-LILLYRX.

Device

Device Recall Forteo teriparatide (rDNA origin) injection starter kits
  • Modelo / Serial
    This product is not lot coded and does not have an expiration date. The kits sucject to this recall were distributed between March 2008 and June 2009. Individuals who receive Forteo therapy are generally prescribed for a period of two (2) years.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Czech Republic, Germany, Slovak Republic, and Switzerland.
  • Descripción del producto
    Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. || Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.
  • Manufacturer
    Eli Lilly and Company

Manufacturer

Eli Lilly and Company
  • Dirección del fabricante
    Eli Lilly and Company, 1555 S. Harding/Lilly Corporate Center, Drop Code 2622, Indianapolis IN 46285-0001
  • Empresa matriz del fabricante (2017)
    Eli Lilly & Company
  • Source
    USFDA